XMRV: How To Screen the Blood Supply

By Amy Dockser Marcus

Last week, members of the HHS Blood XMRV Scientific Working Group told a federal advisory panel that tests to screen the blood supply and donors for the virus XMRV aren’t yet ready for prime time.

But the scientific working group, set up last year after a Science paper found a link between XMRV and chronic fatigue syndrome, is already thinking ahead. Michael Busch, director of Blood Systems Research Institute, the lab that has been coordinating the working group studies, says the researchers are in discussions with FDA and a number of companies about how to design and fund trials that could lead to FDA approval of a blood screening test.

In a webinar on Friday sponsored by the CFIDS Association of America, a patient advocacy group, Busch said that broad screening of the blood supply or potential donors is ”too early to execute” because no reliable test exists yet. He added that studies have yet to be done that would determine if XMRV is transmitted through blood.

Still, Busch told the Health Blog that the HHS working group is in regular communication with both FDA and the NIH about what steps are needed to set up a trial. Grants seeking funding to support these efforts have already been filed and are in the review process, he added.

The working group has also reached out to a number of companies that design and sell blood screening tests for other viruses such as HIV, including Abbott Labs, Gen-Probe, and others that Busch says he cannot yet name. The companies, he says, are being encouraged to scale up efforts to develop tests and think about trial design. ”It takes a long time to develop trials,” Busch says.

Some of the epidemiological studies the working group hopes to launch as part of its investigation into whether XMRV is a threat to the blood supply include taking 2000 specimens from each of five National Heart, Lung and Blood Institute repositories and testing them for XMRV. If the virus consistently turns up, the scientists can then look across the five repositories to see if prevalence remained stable or increased over time. Some of the repositories include so-called linked specimens, taken from both donors and recipients, which would allow determination of transmission through transfusions and possible association with diseases.

Right now, it’s too early to tell whether screening of the blood supply or blood donors is necessary, but Busch says that laying the groundwork is crucial as scientific understanding of XMRV continues to unfold. ”We take this very seriously,” Busch says, adding that the working group wants to be ready ”for when the tests are there and if the data warrants screening.”

Comments (5 of 14)

i was a blood donor most of my life and I was in the WPI study as a healthy control (meaning only that I didn't have a CFS diagnosis -- I did have neuro-endocrine problems that no one including the Mayo Clinic diagnosed successfully). I turned up positive and one year later am pretty sick (fatigue, sore throat, swollen lymph nodes, tumors in my liver and spleen, diarrhea, rapid heartbeat, muscle spasms). I hate to think of what the people who got my blood will go through. I have not given blood for a couple of years and will never do so again but the damage has probably been done.

7:02 am December 22, 2010

Sheila DeRuzza wrote :

As a sufferer of this disease for 28 years I wish they would stop arguing about the XMRV and just do some trials with the meds and see if we can get well. They are wasting precious time to those of us that have been ill for so long. I want my life back and so do millinions of other people. This is a very debilitating disease and is looked upon by many docs as mental illness. What an insult to us that are sick. So let's get working folks and get this fixed ASAP>

10:28 pm December 20, 2010

k. d. wrote :

Ms. Marcus-- I appreciate the thoroughness with which you are delving into this topic. I, likewise, depend upon you for clear, unbiased, detailed reporting on an important health story.

9:00 pm December 20, 2010

MBA wrote :

Thanks for staying on top of this story. I've come to depend on you for accurate, current CFS information.

6:58 pm December 20, 2010

Kit wrote :

Good point cfs since 1998. Thanks for clarifying the allegiances of the CAA.